PKG, 5MM PEEK HANDLE, 45CM
Received Sep 30, 2021 · Event occurred Jul 26, 2021
Report 0002936485-2021-00527 · MDR key 12558407
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
0250181164Catalog number
0250181164
Lot number
1840833K
Product problems
- Arcing
Patient
Unknown
- Blister
- Blister
Narrative
Additional Manufacturer Narrative
THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT PRODUCT ARCED RESULTING IN BLISTERS TO THE PATIENT'S SKIN.
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: ARCING. THE PROBABLE ROOT CAUSES COULD BE USER MISUSE, EXCESSIVE FORCE, NORMAL WEAR, OR IMPROPER STERILIZATION METHODS. THE DEVICE MANUFACTURE DATE IS NOT KNOWN. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem
IT WAS REPORTED THAT PRODUCT ARCED RESULTING IN BLISTERS TO THE PATIENT'S SKIN.